CN115778926A

CN115778926A - Degradable lip care patch containing mussel mucin and preparation method thereof

Info

Publication number: CN115778926A
Application number: CN202310045801.9A
Authority: CN
Inventors: 徐林; 金玉; 徐念沁; 徐松泉; 姜豪; 居丽娜; 刘谋治; 曹晶晶; 黎文清
Original assignee: Nanjing Tzong Blotechnology Co ltd
Current assignee: Nanjing Tzong Blotechnology Co ltd
Priority date: 2023-01-30
Filing date: 2023-01-30
Publication date: 2023-03-14

Abstract

The invention discloses a degradable lip care patch containing mussel mucin and a preparation method thereof, and the degradable lip care patch comprises the following components by mass percent: the film forming agent is 70-90%, the thickening agent is 2-28%, the mussel mucin is 1-5%, and the water is 1-3%, wherein the film forming agent is plant starch which can be degraded by salivary amylase, the mussel mucin is a core effective component, and the film forming agent and the thickening agent effectively protect the biological activity of the mussel mucin, so that the mussel mucin can better play a role in adjuvant therapy on the inflammation part of lips. The invention applies the patch to the auxiliary treatment and nursing of chronic cheilitis for the first time, solves the drug resistance brought by the addition of hormones, antibiotics and other drugs in the existing cheilitis treatment products on the market, makes up the vacancy of patch dosage forms in the cheilitis treatment products, and has good medical and economic values.

Description

Degradable lip care patch containing mussel mucin and preparation method thereof

Technical Field

The invention belongs to the technical field of biology, and relates to a mussel mucin-containing patch, in particular to a mussel mucin-containing degradable lip care patch and a preparation method thereof.

Background

Cheilitis is a general term for inflammatory diseases occurring in the lips. Cheilitis is of various types, and is divided into acute cheilitis and chronic cheilitis according to the course of disease, the chronic cheilitis is the most common, when the chronic cheilitis occurs, lip mucosa is damaged, and the chronic cheilitis is usually accompanied with the characteristics of dryness, desquamation, swelling pain, itching, exudation, scabbing and the like of lips, and the chronic cheilitis repeatedly occurs, and the chronic cheilitis is mild and severe. The etiology of chronic cheilitis is not clear, and the chronic cheilitis is caused by sunlight irradiation, climate change, local stimulation and the like. There are studies reporting that the infectious factors are closely related to the onset of chronic cheilitis, and staphylococcus aureus and candida albicans are the main infectious factors for the onset of chronic cheilitis. Therefore, clinically, antibiotics are usually used and medicines such as growth factors, hormones, vitamins and the like are used in combination to inhibit the growth of staphylococcus aureus and candida albicans at the affected part, so as to achieve the purpose of relieving and treating lip inflammation. However, although drugs such as antibiotics, hormones, vitamins and the like can inhibit lip inflammation, they are resistant to long-term use and cause lip inflammation to be more persistent after long-term use.

Mussel mucin is a high-purity single protein extracted from the foot silk gland of marine mussel and has the functions of promoting cell adhesion crawling, promoting mucosa repair, inhibiting pruritus, forming water-resistant protective film, killing bacteria and resisting inflammation. Research shows that the mussel mucin consists of 70-90 repeated polypeptide fragments, each polypeptide fragment consists of 10 amino acids, 2 of which are lysine, so that the mussel mucin has a high isoelectric point and has strong positive charge at the physiological pH value of a human body; it is reported that each mussel mucin molecule has more than 150 positive charges, and various cells of human bodies such as epidermal cells and the like have negative charges, and the mussel mucin is combined with the cells through electrostatic interaction to promote the adherence and creeping substitution of the epidermal cells, so that the healing of wound surfaces or ulcer surfaces is accelerated. In addition, 10% of DOPA groups (3,4-dihydroxyphenylalanine) exist in the mussel mucin peptide chain segment, some phenolic hydroxyl groups in the DOPA are oxidized into quinone under the condition of a higher pH value, and the oxidized DOPA and unoxidized DOPA are crosslinked to form a high-molecular reticular polymer, so that physical barrier can be effectively formed, the effects of oxidation resistance and inflammation resistance are locally exerted, and the healing of a wound surface is promoted. However, the use of mussel mucin for cheilitis treatment has not been reported.

In addition, most of the products for treating cheilitis on the market at the present stage are in the forms of paste, gel, honey and emulsion, and no patch product appears. Patches are transdermal delivery systems designed to provide a local or systemic therapeutic effect, commonly known as a sheet-like preparation that can be applied to the skin and the drug can provide a systemic or local effect. In addition, many cheilitis patients use lip balm to relieve the discomfort of chapped and dry lips. The paste preparation usually uses mineral oil, petrolatum, etc. to form a protective film on the lips, thereby preventing water loss from chapped lips. The raw materials such as mineral oil and petrolatum usually contain polycyclic aromatic hydrocarbon impurities, and the impurities have the risk of causing cancer.

Therefore, the search for a safe, bacteriostatic, anti-inflammatory and effective treatment method for chronic cheilitis is a problem to be solved urgently.

Disclosure of Invention

Aiming at the existing problems, the invention provides a degradable lip care patch containing mussel mucin and a preparation method thereof, which take the mussel mucin as a core component, develop a degradable patch product which is pasted on the lips, solve the drug resistance caused by the addition of drugs such as hormone, antibiotic and the like in the existing cheilitis treatment product, and also make up the vacancy of the degradable patch in the product dosage form for treating chronic cheilitis in the market. The specific technical scheme is as follows:

firstly, the invention provides a degradable lip care patch containing mussel mucin, which comprises the following components in percentage by mass: 70-90% of film-forming agent, 2-28% of thickening agent, 1-5% of mussel mucin and 1-3% of water; wherein the film forming agent is plant starch capable of being degraded by salivary amylase.

Preferably, the film forming agent is one or more of corn starch, tapioca starch, wheat starch, potato starch, mung bean starch, water chestnut starch, lotus root starch or kudzu root starch.

Preferably, the film forming agent is one or more of corn starch, tapioca starch, wheat starch or potato starch.

Preferably, the content of the film forming agent accounts for 70-80%, and more preferably 70% of the total mass of the degradable lip care patch.

Preferably, the thickener is one or more of xanthan gum, carrageenan, pectin, gelatin, hydroxyethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol or sodium polyacrylate.

Preferably, the thickener comprises one or more of xanthan gum, hydroxyethyl cellulose, hydroxypropyl methylcellulose or polyethylene glycol.

Preferably, the content of the thickener is 15 to 25%, more preferably 25% of the total mass of the degradable lip care patch.

Secondly, the invention provides a preparation method of the degradable lip care patch containing the mussel mucin, which comprises the following steps:

1) The mussel mucin, the film forming agent, the thickening agent and water are stirred and mixed evenly to form a suspension system, wherein the addition amount of the water is 0.8 to 2 times of the total mass of the mussel mucin, the film forming agent and the thickening agent;

2) Defoaming the suspension system obtained in the step 1 by adopting a vacuum stirring method to obtain a patch coating liquid;

3) And uniformly coating the defoamed patch coating liquid on a backing material by using a film coating machine, drying at 35-65 ℃, and demoulding to obtain the degradable lip care patch containing the mussel mucin.

Preferably, in the step 1), the addition amount of the water is 1-1.5 times of the mass sum of the mussel mucin, the film forming agent and the thickening agent; the additive amount of mussel mucin is 3% of the total mass of the degradable lip care patch

Preferably, in step 3), the patch coating liquid is coated on the backing material to a thickness of 1mm to 5mm.

Preferably, in step 3), the patch coating liquid is coated on the backing material to a thickness of 2mm to 3mm.

Preferably, in the step 3), the drying temperature is 40 ℃ and the drying time is 60min; the water content of the dried lip paste is 2%.

The invention has the beneficial effects that:

1) The degradable lip care patch takes biomacromolecule mussel mucin as a core component, applies the specific capabilities of sterilization, anti-inflammation, film forming and promotion of mucosa and wound healing of the mussel mucin to the auxiliary treatment of chronic cheilitis, and solves the drug resistance brought by the addition of drugs such as hormone, antibiotic and the like in the existing cheilitis treatment products in the market.

2) The degradable lip care patch of the invention applies a skin transdermal administration dosage form, namely the patch, to the auxiliary treatment and care of chronic cheilitis for the first time, and makes up the vacancy of the patch dosage form in cheilitis treatment products.

3) The degradable lip care patch takes starch substances which can be specifically degraded by salivary amylase as a patch film material, the care patch is pasted on a chronic cheilitis part, and after the film material is degraded by the salivary amylase, a core component mussel mucin plays an auxiliary treatment effect on the inflammation part.

4) In the degradable lip care patch prepared by the invention, the film-forming agent and the thickening agent effectively protect the biological activity of the mussel mucin, so that the mussel mucin can better play a role in adjuvant therapy on the inflammation part of lips.

Drawings

FIG. 1 is a degradable lip care patch of the present invention containing mussel mucin;

fig. 2 is an amylase degradation of a mussel mucin-containing degradable lip care patch of the invention.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to the embodiments.

Example 1

This example is a degradable lip care patch containing mussel mucin and a method of making the same. The degradable lip care patch comprises the following components in percentage by mass: 70-90% of film-forming agent, 2-28% of thickening agent, 1-5% of mussel mucin and 1-3% of water. Wherein, the film forming agent is plant starch which can be degraded by salivary amylase, and the content of the film forming agent is preferably 70-80 percent of the total mass of the degradable lip care patch, and more preferably 70 percent; the film forming agent can be one or more of corn starch, tapioca starch, wheat starch, potato starch, mung bean starch, water chestnut starch, lotus root starch or kudzu root starch, preferably one or more of corn starch, tapioca starch, wheat starch or potato starch; more preferably corn starch. The content of the thickening agent is preferably 15-25% of the total mass of the degradable lip care patch, and is further preferably 25%, wherein the thickening agent is one or more of xanthan gum, carrageenan, pectin, gelatin, hydroxyethyl cellulose, hydroxypropyl methyl cellulose, polyethylene glycol or sodium polyacrylate; more preferably xanthan gum. The preparation method of the degradable lip care patch comprises the following steps:

1) The mussel mucin, the film forming agent, the thickening agent and water are stirred and mixed evenly to form a suspension system, wherein the addition amount of the water is 0.8 to 2 times, preferably 1 to 1.5 times of the total mass of the mussel mucin, the film forming agent and the thickening agent; the additive amount of mussel mucin is 3% of the total mass of the degradable lip care patch;

3) Uniformly coating the defoamed patch coating liquid on a backing material by using a coating machine, wherein the coating thickness is 1-5 mm, and preferably 2-3 mm; then drying at 35-65 ℃, preferably drying at 40 ℃ for 60min; the water content of the dried lip paste is 2%; finally, demoulding to obtain the degradable lip care patch containing the mussel mucin, as shown in figures 1 and 2.

Example 2

This example is to examine the effect of the water addition and the ratio of the solid content addition (film forming agent, thickener, mussel mucin) on the film forming properties of the final patch during the preparation of the degradable lip care patch described in example 1. The film forming effect of the patch is inspected by changing the proportion of the total addition amount of water and solid components in the preparation process of the patch by using corn starch as a film forming agent and xanthan gum as a thickening agent. Adding water and solid substances at the mass ratio of 0.8/1, 1/1, 1.2/1, 1.5/1, 1.8/1 and 2/1, mixing the raw materials uniformly, and defoaming by a vacuum stirring method to obtain a patch coating liquid; the defoamed patch coating solution was uniformly coated on a smooth backing material PE film by a film coating machine to a coating thickness of 2mm, and after uniform coating, it was further dried at 40 ℃ for 60min to prepare a patch, and the results are shown in table 1.

TABLE 1 influence of Water and solid component addition ratio on film Forming Properties of Patches

As can be seen from table 1, when the ratio of the amount of water added to the amount of solid added is less than 1/1 during the preparation of the patch, the suspension obtained by mixing water and solid has a high viscosity, and cannot be uniformly coated on a coating machine after vacuum degassing, and the dried patch has a chapping phenomenon. When the ratio of the addition amount of water to the addition amount of the solid component is higher than 1.5/1, the water content of a suspension system obtained by mixing water and the solid component is too high, the viscosity of the system is low, and the sagging phenomenon can occur when the suspension system is coated on a coating machine after vacuum defoaming, so that finally prepared membranes can be wrinkled, and membranes with uniform thickness cannot be prepared. When the ratio of the addition amount of water to the addition amount of the solid component is 1-1.5/1, the membrane with proper water content and uniform thickness can be finally prepared, and when the ratio of the addition amount of water to the addition amount of the solid component is 1.2/1, the finally prepared membrane is optimal.

Example 3

In order to investigate the influence of the coating thickness on the final product on a coating machine after a mixed system of a film forming agent, a thickening agent, mussel mucin and water is defoamed in vacuum in the preparation process of the patch. Taking corn starch as a film forming agent and xanthan gum as a thickening agent, wherein the ratio of the total addition amount of water to solid components is 1.2/1 in the preparation process of the patch, uniformly mixing the raw materials, and defoaming by a vacuum stirring method to obtain a patch coating liquid; the deaerated patch coating liquid was uniformly applied to a flat backing material PE film by a film coater to a thickness of 1mm, 2mm, 3mm, 4 mm, and 5mm, respectively, and after uniform application, dried at 40 ℃ for 60min to prepare a patch, and the influence of the coating thickness was examined from two dimensions of the mechanical strength and the degree of adhesion to the lips of the obtained patch, and the results are shown in table 2.

TABLE 2 influence of coating thickness on film Forming Properties of adhesive preparations

As can be seen from Table 2, when the thickness of the mixed system coating is less than 2mm, the prepared patch has poor mechanical strength and is easy to break; when the thickness of the mixed system coating is more than 2mm, the prepared patch has good mechanical strength, but has poor fit with lips; overall, the optimum coating thickness for the mixed system was 2 mm.

Example 4

This example is to examine the effect of moisture content in the degradable lip care patch product described in example 1 on the properties of the patch. The preparation method comprises the following steps of taking corn starch as a film forming agent and xanthan gum as a thickening agent, wherein the ratio of the total addition amount of water to solid components is 1.2/1 in the preparation process of the patch, uniformly mixing the raw materials, and defoaming by a vacuum stirring method to obtain a patch coating liquid; uniformly coating the defoamed patch coating liquid on a flat backing material PE film by using a coating machine, wherein the coating thickness is 2mm respectively, uniformly coating, drying at 40 ℃ for 60min, preparing a patch, detecting the water content of a final product, screening patch products with the water contents of 1%, 2% and 3%, and inspecting the influence of the water content of the final product from two dimensions of mechanical strength and adhesion of the obtained patch, wherein the result is shown in Table 3.

TABLE 3 Effect of moisture content in degradable lip care patch products on Patch Properties

Although the addition amount of raw materials is fixed with the preparation process in the preparation process, the error of about 1 percent of the water content of the final product still occurs. The purpose of this example was to examine the effect of errors in water content of the final product on the patch final product. As shown in table 3, when the final product water content was 3%, the patch was soft and poor in mechanical strength; when the water content of the final product is 1%, the mechanical strength of the patch is good, but the patch is dry and poor in adhesiveness; comprehensively, when the water content of the final product is 2%, the mechanical strength and the adhesiveness of the patch are excellent, and the requirement of lip use is met.

Example 5

This example considers the effect of mussel mucin content in the patch product prepared from two dimensions of bacteriostatic and anti-inflammatory activity. The preparation method comprises the following steps of taking corn starch as a film forming agent and xanthan gum as a thickening agent, wherein the ratio of the total addition amount of water to solid components is 1.2/1 in the preparation process of the patch, uniformly mixing the raw materials, and defoaming by a vacuum stirring method to obtain a patch coating liquid; uniformly coating the defoamed patch coating liquid on a flat backing material PE film by using a coating machine, wherein the coating thickness is 2mm, and drying at 40 ℃ for 60min after uniform coating to prepare the patch. In the embodiment, 6 patch formulas with the mussel mucin contents of 0%, 1%, 2%, 3%, 4% and 5% are prepared, the xanthan gum content is unchanged, the corn starch content is increased or decreased along with the mussel mucin content, the water content of a final patch product is controlled to be 2%, and the mechanical strength and the adhesion of the patch product are guaranteed. The final formulation is shown in table 4.

TABLE 4 degradable lip care patch formulations with different mussel mucin content

This example investigates the effect of mussel mucin content in the final patch product from two dimensions of bacteriostatic and anti-inflammatory activity:

(1) Bacteriostatic activity

According to WS/T650-2019 & methods for evaluating antibacterial and bacteriostatic effects, the patch products of formulas 1-6 are tested for bacteriostatic activity. The bacteriostatic difference is compared by measuring the survival amount of microorganisms contacted for a certain time through the contact of the patch sample and the bacterial suspension at regular time and quantity, and the microorganisms select representative staphylococcus aureus and candida albicans.

The test procedure was as follows:

1) Preparation of bacterial suspension

Staphylococcus aureus: sterile PBS dilution to 4.0X 10 ⁶ CFU/mL；

Candida albicans: sterile PBS dilution to 4.0X 10 ⁶ CFU/mL。

2) Test procedure

Preparing the bacteriostatic tablets: formulations 2-6 patch products were cut into circular discs 5mm in diameter and 2mm in thickness, with 1 set of 4 patches per formulation.

Preparation of negative control sample: the formulation 1 patch product was cut into discs of the same size as the test groups.

Dipping with sterilized cotton swab to obtain the extract with concentration of 4.0 × 10 ⁶ CFU/mL test bacterial suspension was evenly spread on the surface of a suitable medium plate 3 times. For each application 1 time, the plate was rotated 60 °, and finally the cotton swab was applied around the edge of the plate for one revolution. The plate was covered and dried at room temperature for 5 min.

Each test is stuck with 1 infectious bacterium plate, and each plate is stuck with 4 test sample plates and 1 negative control sample plate, and the number of the negative control sample plates is 5. And (3) using sterile tweezers to take a sample piece and stick the sample piece on the surface of the flat plate, sticking a negative control sample piece on the central position of the flat plate, sticking test sample pieces around the sample piece, and after sticking the sample pieces, lightly pressing the sample pieces by using the sterile tweezers to enable the sample pieces to cling to the surface of the flat plate. The distance between the centers of the various pieces is 25 mm or more, and the distance between the centers of the various pieces and the peripheral edge of the flat plate is 15 mm or more. The plate was covered, and the plate was incubated at 36. + -. 1 ℃ for 18 h, and the experiment was repeated 3 times.

The diameter of the antibacterial ring was measured with a vernier caliper and recorded. The result judgment standard is as follows: the negative control sample is judged to have the bacteriostatic action if no bacteriostatic ring is generated and the diameter of the bacteriostatic ring of the test sample is greater than 7 mm; the diameter of the bacteriostatic ring is less than or equal to 7 mm, and the bacteriostatic ring is judged to have no bacteriostatic action. The results are shown in Table 5 (the table only records the average diameter of the zone of inhibition in each test group for each test).

TABLE 5 Effect of mussel mucin content on bacterial inhibition by degradable lip care patches

As can be seen from table 5, when no mussel mucin is present in the patch (formulation 1), the patch is not bacteriostatic for both staphylococcus aureus and candida albicans. When the addition amount of the mussel mucin in the patch is increased from 1% to 3%, the patch has antibacterial activity to staphylococcus aureus and candida albicans, and the antibacterial activity is increased along with the increase of the content of the mussel mucin. When the addition amount of the mussel mucin is further increased, the bacteriostatic activity of the patch on staphylococcus aureus and candida albicans is not obviously increased, so that the addition amount of the mussel mucin of 3% is selected to be optimal.

(2) Anti-inflammatory Activity

Tumor necrosis factor (TNF-alpha) and interleukin-6 (IL-6) are the most common and important inflammatory mediators in the inflammatory reaction process, and can cause inflammation symptoms such as red swelling and hot pain. By reducing the levels of these factors, the extent of the inflammatory response can be controlled. Assays Lipopolysaccharide (LPS) intervention was used to build an inflammatory cell model in macrophages and the anti-inflammatory activity of mussel mucin-containing degradable lip care was assessed by measuring the levels of TNF-alpha and IL-6 therein. Because the film-forming material in the lip care patch is a starch substance which is insoluble in water, the mussel mucin with the corresponding concentration in the formula 1-6 is selected for anti-inflammatory activity detection. The test group was added with a medium containing mussel mucin and LPS (1. Mu.g/ml) at the concentrations corresponding to the formulations, the negative control group was added with a cell culture medium containing LPS (1. Mu.g/ml), and the contents of TNF-. Alpha.and IL-6 were measured by ELISA assay kit, and the results of the assay are shown in Table 6.

TABLE 6 Effect of different mussel mucin content on anti-inflammatory Activity of degradable lip care patches

As can be seen from Table 6, mussel mucin has significant inhibitory activity on inflammatory factors TNF-alpha and IL-6, and when the concentration of mussel mucin is increased from 1% to 3%, the inhibitory activity on inflammatory factors is increased along with the increase of the concentration; when the concentration of mussel mucin was further increased, there was no further increase in the inhibitory effect on the inflammatory factors TNF-. Alpha.and IL-6. Therefore, a mussel mucin concentration of 3% is the optimal concentration in this patch.

Example 6

This example is to examine whether different film forming agents and thickeners can be made into a patch. Representative film forming agents and thickening agents were selected and lip care patches were prepared separately. The content of the film forming agent is 70 percent, the content of the thickening agent is 25 percent, the content of the mussel mucin is 3 percent, and the water content is controlled to be 2 percent. The preparation process of the patch is that the proportion of the total adding amount of water and solid components is controlled to be 1.2/1, the vacuum stirring method is adopted for defoaming after the uniform mixing, the coating machine is adopted for uniformly coating the coating liquid of the patch after the defoaming on a PE film which is a smooth backing material, the coating thickness is 2mm, the coating liquid is dried for 60min at 40 ℃ after the uniform coating, and the patch is prepared, as shown in tables 7 and 8.

TABLE 7 degradable lip care patches made with different film forming agents

TABLE 8 degradable lip care patches made with different thickeners

It follows that representative film forming agents and thickeners can be used to form lip care patches. And each film forming agent can be specifically degraded by salivary amylase, the nursing patch is applied to a chronic cheilitis part, and after the film material is degraded by the salivary amylase, the auxiliary treatment effect of core component mussel mucin on the inflammation part is facilitated.

Example 7

This example is to examine the effect of the content of film-forming agent and thickener on the degradation time of a mussel mucin-containing lip care patch. The method comprises the following steps of taking corn starch as a film forming agent and xanthan gum as a thickening agent, controlling the proportion of the total addition amount of water and solid components to be 1.2/1, uniformly mixing, defoaming by adopting a vacuum stirring method, uniformly coating a patch coating liquid on a flat backing material PE film by adopting a coating machine, wherein the coating thickness is 2mm, and drying at 40 ℃ for 60min after uniform coating to prepare a patch product. The prepared patch was degraded with 1% by mass of salivary amylase, and the test results are shown in table 9.

TABLE 9 Effect of film Forming agent and thickener content on degradation time of Patch

As can be seen from Table 9, as the proportion of film forming agent increased, the time for the salivary amylase to degrade the patch product increased, i.e., the degradation time of the patch correlated positively with the amount of film forming agent. In daily life, the degradation time of the lip patch is too long, which affects the normal life of a user, so that the degradation time of the lip patch is preferably controlled within 5min, and therefore, the content of the film forming agent is preferably controlled to be 70-80%, the content of the film forming agent is preferably controlled to be 70%, and the degradation time is preferably 1 min.

Example 8

This example is to investigate the protective effect of film forming agents and thickening agents in patches on mussel mucin. In this example, the patch product prepared by formulation 13 in example 7 and a mussel mucin aqueous solution with a mass concentration of 3% were respectively placed in artificial saliva, stirred at 32 ℃ ± 1 ℃ for 10min at a stirring speed of 50r/min, the mixed system after stirring was respectively centrifuged, and the centrifuged supernatant was subjected to the detection of anti-inflammatory activity, which was performed in the same manner as in example 4, and the test results are shown in table 10.

TABLE 10 protective Effect of film-formers and thickeners on mussel mucins

As shown in table 10, the anti-inflammatory activity of the aqueous solution of mussel mucin at a mass concentration of 3% is lost after the treatment with artificial saliva because the artificial saliva contains a large amount of protease, which degrades the mussel mucin, the mussel mucin structure is destroyed, and the anti-inflammatory activity is lost. The lip care patch containing the mussel mucin can still effectively reduce the content of inflammatory factors TNF-alpha and IL-6 after being treated by artificial saliva for 10min, which shows that the film forming agent and the thickening agent in the patch can effectively protect the mussel mucin from being degraded by protease in the artificial saliva. Presumably, the film-forming agent and the thickener contain a large amount of carboxyl and hydroxyl groups, and the carboxyl and hydroxyl groups can be combined with peptide bonds of protease in the artificial saliva through non-covalent acting force, so that the interaction of the protease in the artificial saliva and the mussel mucin is prevented, the degradation of the mussel mucin by the protease is further prevented, and the biological activity of the mussel mucin is protected. This example strongly demonstrates that film-forming agents and thickening agents in a patch can protect the biological activity of mussel mucin.

Example 9

This example is to demonstrate the effectiveness of the prepared mussel mucin-containing lip care patch in the treatment of chronic cheilitis.

This example was carried out on 22 volunteers of chronic cheilitis patients under clinical laboratory observation. Dividing 22 patients into a control group and a treatment group according to the group-entering sequence, wherein 11 patients in the control group, 6 patients in the male group, 5 patients in the female group and the age of 14-33 years old; the treatment groups were 11, 5 men and 6 women, aged 15-35 years. The disease course of the two groups is 1-30 months, and the two groups have no obvious difference in sex, age and disease course and have comparability.

The treatment regimen of this example was:

control group: the prevention of irritation factors is the primary treatment measure, such as changing bad habits of biting lips, licking lips and the like, giving up smoking, alcohol, spicy food and the like, and meanwhile, medical glycerin is smeared on the chronic cheilitis part for 2 times a day, 1 month is 1 treatment course, and 1 treatment course is total.

Treatment groups: the prevention of the irritation factor is the primary treatment measure, for example, bad habits of lip biting, lip licking and the like are changed, smoking and alcohol, spicy food and the like are eliminated, meanwhile, the lip care patch prepared by the formula 13 is applied to the chronic cheilitis part, 2 times a day, 1 month is 1 treatment course, and 1 treatment course is total.

And (3) evaluating the curative effect: the efficacy was judged by desquamation and incrustation: 0 is no desquamation and scabs are formed; 1, the lip part is slightly desquamated and does not scab; 2, lip obviously desquamation and scab at partial desquamation parts are divided; 3, the lip part is obviously scabbed, is opened, and bleeds when the lip part is taken; 4, desquamation, incrustation and skin around mouth are divided.

The results of clinical observations of the control group and the treatment group are shown in tables 11 and 12.

TABLE 11 summary of scores before and after treatment for control group

TABLE 12 summary of scores before and after treatment for treatment groups

As shown in tables 11 and 12, the desquamation and crusting scores of chronic cheilitis patients were significantly better than the scores of the chronic cheilitis patients after the treatment with the lip care patch containing mussel mucin. After the chronic cheilitis patients in the control group are treated by medical glycerin in an auxiliary way, the score of cheilitis parts is slightly reduced, and the moisturizing property of glycerin is proved to be helpful for healing the chronic cheilitis. After a treatment course of chronic cheilitis patients treated by the patch provided by the invention, the score of cheilitis sites is obviously reduced, and the average score of 11 subjects is reduced from 3 to 0.91, so that the effectiveness of the lip care patch provided by the invention on adjuvant therapy of chronic cheilitis is strongly proved.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. Furthermore, it should be understood that although the present specification describes embodiments, this does not include only one embodiment, and such description is for clarity only, and those skilled in the art should be able to make the specification as a whole, and the embodiments may be appropriately combined to form other embodiments understood by those skilled in the art.

Claims

1. A degradable lip care patch containing mussel mucin is characterized in that: the composition comprises the following components in percentage by mass:

70 to 90 percent of film-forming agent,

2 to 28 percent of thickening agent,

1 to 5 percent of mussel mucin,

1 to 3 percent of water;

wherein the film forming agent is plant starch capable of being degraded by salivary amylase.

2. The mussel mucin-containing degradable lip care patch according to claim 1, wherein: the film forming agent is one or more of corn starch, cassava starch, wheat starch or potato starch.

3. The mussel mucin-containing degradable lip care patch according to claim 2, wherein: the content of the film forming agent accounts for 70-80% of the total mass of the degradable lip care patch.

4. The mussel mucin-containing degradable lip care patch according to claim 1, wherein: the thickener comprises one or more of xanthan gum, hydroxyethyl cellulose, hydroxypropyl methylcellulose or polyethylene glycol.

5. The mussel mucin-containing degradable lip care patch according to claim 4, wherein: the content of the thickening agent accounts for 15-25% of the total mass of the degradable lip care patch.

6. A method for preparing a degradable lip care patch containing mussel mucin is characterized in that: the method comprises the following steps:

2) Defoaming the suspension system obtained in the step 1) by adopting a vacuum stirring method to obtain a patch coating liquid;

7. The method of making a mussel mucin-containing degradable lip care patch according to claim 6, wherein: in the step 1), the addition amount of the water is 1-1.5 times of the mass sum of the mussel mucin, the film-forming agent and the thickening agent.

8. The method of making a mussel mucin-containing degradable lip care patch according to claim 6, wherein: in the step 3), the coating thickness of the patch coating liquid on the backing material is 1mm to 5mm.

9. The method of making a mussel mucin-containing degradable lip care patch according to claim 8, wherein: in the step 3), the coating thickness of the patch coating liquid on the backing material is 2mm to 3mm.

10. The method of making a mussel mucin-containing degradable lip care patch according to claim 8, wherein: in the step 3), the drying temperature is 40 ℃, and the drying time is 60min.